Montelukast (Singulair®) and neuropsychiatric events
admin January 16th, 2009
The FDA review of montelukast has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events with montelukast. Although initial analysis of trial data supplied by companies has not shown a link, there is an ongoing analysis which may take months to report. The FDA are suggesting healthcare professionals should be aware of post-marketing case reports of neuropsychiatric events in the interim:
Post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton have been reported to FDA’s Adverse Event Reporting System (AERS). Most of the reports of neuropsychiatric events are associated with montelukast, currently the most commonly prescribed drug that acts through the leukotriene pathway. The clinical details of some reports involving montelukast are consistent with a drug-induced effect. Because of the paucity of reports involving zafirlukast and zileuton, assessment of a drug–induced effect with these is limited. Accordingly, at this time, patients and prescribers should monitor for the possibility of neuropsychiatric events associated with these agents.
- FDA
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